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Questions and Answers: Saccharin

Issue: Health Canada is considering re-listing saccharin as a food additive in Canada following the evaluation of data indicating that it is not carcinogenic to humans.

Q 1. Saccharin use in Canada has been restricted for so long. Why consider allowing it now as a food additive?

A 1. Health Canada's Food Directorate reviewed data supporting the safety of saccharin that was produced after the restriction came into place. This was done in response to a food additive submission to re-list saccharin for use in a variety of foods in Canada from an interested stakeholder. Health Canada completed its evaluation and is in agreement with the international opinion that saccharin could be safely used in foods.

Many countries in the world, but not Canada, currently permit saccharin to be used as a non-nutritive sweetening agent in foods.

Q 2. How do we know saccharin is safe?

A 2. In the 1970's, studies demonstrated that sodium saccharin was carcinogenic in laboratory rats. On this basis, saccharin was de-listed as a food additive in Canada, although restricted access as a table top sweetener was maintained. Since that time, further studies have suggested that the carcinogenic effect of sodium saccharin in rats is not relevant to humans. Both the Joint Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO) Expert Committee on Food Additives, and the European Commission's Scientific Committee on Foods have established an acceptable daily intake (ADI) level for sodium saccharin and Health Canada is proposing to introduce a similar ADI. The International Agency for Research on Cancer has conducted a complete evaluation of saccharin's carcinogenic potential in humans and has concluded that sodium saccharin can no longer be considered a "possible carcinogen in humans". In May 2000, the U.S. National Toxicology Program (NTP) dropped saccharin from its list of suspected cancer-causing chemicals, indicating that the rodent carcinogenicity data are not sufficient to list this chemical as a "reasonably anticipated human carcinogen."

Q 3. Why is allowing saccharin as a food additive necessary when there are many other artificial sweeteners already available in Canada?

A 3. The scientific evidence indicates that saccharin is safe, so allowing manufacturers to use saccharin as a food additive in their products would provide another sweetner option, improving consumer selection and choice.

Q 4. How were the intake limits of saccharin decided?

A 4. Saccharin intake calculations were based on the conservative assumption that all of the sweetened foods (in a person's regular diet) ingested contain saccharin; that each food contains saccharin at the maximum use limit; and that saccharin is used exclusively as the only sweetener in each food (i.e. uncombined with other sweeteners). The results suggest that under current market conditions, the likelihood of long term consumption of saccharin in excess of the ADI is remote. However, if patterns of use in the marketplace change, some product categories might contribute to excessive exposures in some age groups, and merit ongoing review and monitoring. On the other hand, these exposure simulations were conducted under the assumption that saccharin was the only sweetener used in these foods, and therefore overestimate exposure. Increasingly, sweeteners are used in admixture (in combination with other sweeteners).

Q 5. What is the status of saccharin now? What are the next steps?

A 5. For some time, saccharin has been available at retail for personal discretionary use only. Foods containing saccharin would be sold once the process for re-listing saccharin as a food additive is complete. This process involves "pre-publication" of the proposed regulation in the Canada Gazette Part I, the official newspaper of the Government of Canada. A period of time is then provided for public comment. If no substantial concerns are raised, a regulation allowing the addition of saccharin to retail foods would be approved, registered, and then published in the Canada Gazette Part II.

Health Canada is following the Government of Canada Regulatory Policy established by the Treasury Board Secretariat, which must be followed by all Departments and Agencies that intend to have regulations approved by the Governor in Council. This is a detailed process which includes several steps and the duration of each step depends on the problem being addressed and the complexity of the file. Once proposed amendments for re-listing of saccharin are pre-published in Canada Gazette Part I, a comment period will be provided to allow interested parties an opportunity to comment on the proposed regulations. The comments received will need to be considered prior to publication of the final regulatory amendments in Canada Gazette Part II. This process may take up to two years.

Q 6. Is saccharin safe for consumption by pregnant or breastfeeding women?

A 6. The scientific evidence revealed that saccharin can be safely consumed by humans, including pregnant and breastfeeding women. However, for nutritional reasons, pregnant women should be cautioned against excessive consumption of products containing artificial sweeteners since such foods could be replacing nutrient-dense, energy-yielding foods. Further guidance on nutrition during pregnancy can be found in the Health Canada publication Nutrition for a Healthy Pregnancy:National Guidelines for the Childbearing Years.